Actively Recruiting

Phase Not Applicable
Age: 16Years - 65Years
All Genders
Healthy Volunteers
NCT05480150

Chinese Longitudinal and Systematic Study of Bioplar Disorder

Led by First Affiliated Hospital of Zhejiang University · Updated on 2022-10-17

10000

Participants Needed

1

Research Sites

269 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Affective disorders (mainly including major depressive disorder and bipolar disorder) are common, chronic and highly disabling mental disorders, which lack of objective biological markers. It is believed that genetic and environmental factors are involved in the development of affective disorders. Gut microbes can affect the function of brain neural circuits by mediating metabolic, immune, endocrine and autonomic changes along the brain-gut axis. The brain can also regulate intestinal microbes through endocrine, neural structure, neurogenic exosomes and other pathways. Based on the brain-gut axis, this study intends to establish a large cohort of affective disorders, and screen out efficient and convenient biomarkers for clinical diagnosis and efficacy prediction by studying key indicators such as intestinal microbes, serum metabolites and immune indexes, brain-derived exosomes, and brain functional imaging.

CONDITIONS

Official Title

Chinese Longitudinal and Systematic Study of Bioplar Disorder

Who Can Participate

Age: 16Years - 65Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Both biological parents are Han nationality
  • Aged 16 to 65 years
  • Meet DSM-5 clinical diagnostic criteria for depressive episodes of major depressive disorder or bipolar disorder
  • Have not taken immunomodulatory medications within 1 month before enrollment
  • No clear history of respiratory, urinary, or digestive infections within 1 month before enrollment
Not Eligible

You will not qualify if you...

  • Diagnosed with schizophrenia spectrum, neurodevelopmental disorders, dementia, memory impairment, or other cognitive impairments per DSM-5
  • Mental disorders caused by substance abuse, or serious physical or immune system diseases such as diabetes, thyroid diseases, hypertension, heart disease, liver or kidney dysfunction, autoimmune diseases
  • Received antidepressants, antipsychotics, mood stabilizers, or similar medications within 1 month before enrollment
  • Previously treated with electroconvulsive therapy
  • Currently have serious suicidal thoughts, behaviors, or severe excitement
  • Unable to follow doctor's advice or lack a guardian
  • Pregnant, breastfeeding, or planning to become pregnant
  • Have contraindications to MRI examination
  • Any other condition the researcher deems inappropriate for study participation

AI-Screening

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Trial Site Locations

Total: 1 location

1

The First Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, China, 310000

Actively Recruiting

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Research Team

S

Shaohua Hu

CONTACT

Y

Yanmeng Pan

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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